CAREERS AT VYERA
Be a Part of the Vyera Vision
At Vyera, you can build a career that makes a valuable difference. We are proud to work with some of the most talented colleagues across the science, business and pharmaceutical industries. Together, we can vastly improve the lives of people who live with rare and serious diseases while driving a path forward in innovative medicinal advancements. Our team is seeking dedicated individuals to join our growing organization and contribute to finding solutions for some of our patients’ most critical challenges. Join us in implementing Vyera’s vision of patients living longer and healthier lives. Apply to one of our open positions today!
We Welcome Applications from All Qualified Candidates
We're looking for people who are passionate about identifying, creating and bringing to market therapies that can change the lives of underserved patients. We believe diversity is essential to creating a truly innovative and dynamic environment. To ensure that we support an atmosphere where innovative thinking can thrive, we look for applicants from a range of backgrounds and with a variety of work and life experiences.
If you’re interested in a career at Vyera, take a look at our current openings to find the best fit for your talents. Click any title to see a relevant job description and to submit your application for that position. If you have already submitted or saved an application, click My Account to retrieve it. For general applications, please send your resume to email@example.com.
Vyera Is an Equal Opportunity Employer
Vyera Pharmaceuticals, LLC is an Equal Opportunity employer. We are committed to the hiring, advancement and fair treatment of all individuals and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state, or local law. For more information about your rights as an applicant: EEO is the Law and EEO is the Law Supplement.
|Title:||Director, Clinical Research|
|Department:||Clinical Development & Clinical Operations|
|Number of Openings:||1|
SUMMARY OF POSITION
The Director of Clinical Research will possess extensive experience in advancing clinical trials successfully. A background in Infectious and/or Rare diseases is preferred, but experience in other related specialties may be considered. The successful candidate will bring a robust knowledge of protocol design, experience working with Key Opinion Leaders and overseeing, implementing and executing successful clinical trials to the position. The candidate will be a strong leader and strategic thinker, with experience in a high productivity environment.
MAJOR ACTIVITIES AND RESPONSIBILITIES
- Responsible for clinical development strategies including Phase I through III, lifecycle management, safety responsibilities, scientific interactions with regulatory bodies, and interactions with corporate partner(s).
- Leads and oversees the strategic definition and tactical development of clinical study programs, including protocol writing, interpretation of clinical data, and literature reviews.
- Ensures the consistent application of state-of-the-art scientific and ethical methods to design clinical investigational studies of the highest quality.
- Ensures that all clinical studies are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical study execution.
- Ensures the work with colleagues and collaborators is coordinated, and that all people, systems, processes and materials required for clinical studies are available and appropriately prepared.
- Supervises and directs the activities of the Clinical Research staff.
- Ensures that clinical studies are conducted in accordance with applicable regulatory requirements and guidelines.
- Ensures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations, resulting in appropriate negotiation of contracts.
- Ensures timely medical review and reporting of adverse events associated with clinical studies.
- In conjunction with Regulatory Affairs, ensures the timely preparation of quality clinical study documents to be submitted to the FDA and other health authorities in support of regulatory applications e.g. INDs, NDAs etc.
- Ensures the timely preparation of presentations reporting results of clinical studies to internal and external audiences.
- Collaborates with colleagues in the discovery research and preclinical development line functions to move product candidates for entry into clinical investigations.
- May represent the Clinical Research line function on multidisciplinary project teams.
- Works with marketing to evaluate product candidates and determine product indications, as appropriate.
- MD, MD/PhD with 5+ years of experience in investigational drug development.
- Experience in a related therapeutic area such as Infectious Disease, Rare Disease or other related specialty.
- Pharmaceutical industry experience in the successful development and registration of new drug products is preferred.
- Experience in pharmaceutical or biotech industry working with Phase I - III clinical trials, and/or serving as principal investigator with a background in clinical study design and protocol development.
- Thorough knowledge of ICH guidelines and FDA requirements related to clinical research.
- A working knowledge of biostatistics as relevant to the design and analysis of clinical studies.
- Prior experience at senior levels working in and/or leading cross-functional teams.
- Team player with executive presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities.
- Comfortable working both internally and externally with technical and medical experts in providing input into future drug development strategies.
- Experience presenting clinical programs to health authorities e.g. FDA, EMA is preferred.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style
- Some travel required
Notice to Recruiters
Vyera's Human Resources Department manages the recruitment and employment process for the Company, and all candidates must be presented through this Department. If your agency wishes to establish a relationship with Vyera, you must work directly with the Human Resources Department. Contacting our hiring managers or employees directly is not appropriate. For more details, please email firstname.lastname@example.org.
For the protection of all parties involved, Vyera will only accept resumes from recruiters if an executed agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Vyera from recruiters do not constitute any type of relationship between the recruiter and Vyera and do not obligate the Company to pay fees should we hire from those resumes.